Cleared Traditional

K092479 - SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL

K092479 is an FDA 510(k) clearance for SDX-SPIRODYNR'X RADIOTHERAPY BREATHING ..., manufactured by Dyn'R. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K092479 · Dyn'R · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
151d
Days
Class 2
Risk

K092479 is an FDA 510(k) clearance for the SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Dyn'R (Muret, FR). The FDA issued a Cleared decision on January 11, 2010 after a review of 151 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dyn'R devices

FDA 510(k) Submission Details - K092479

510(k) Number K092479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2009
Decision Date January 11, 2010
Days to Decision 151 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 107d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 395
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K092479.
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2
K102671 · Siemens Medical Solutions USA, Inc. · Oct 2010
VARIAN HIGH ENERGY LINEAR ACCELERATOR
K100890 · Varian Medical Systems · Jul 2010
VARIAN TREATMENT
K093967 · Varian Medical Systems, Inc. · Jul 2010
ARIA RADIATION ONCOLOGY WITH MIRS
K093527 · Varian Medical Systems, Inc. · Dec 2009
TRILOGY MX
K092871 · Varian Medical Systems, Inc. · Nov 2009
160MLC OPTION
K092145 · Siemens Medical Solutions USA, Inc. · Sep 2009